Search Results
Found 1 results
510(k) Data Aggregation
K Number
K031319Device Name
OSTEO-G BONE VOID FILLER SYSTEM
Manufacturer
ASPINE USA, INC.
Date Cleared
2003-07-17
(83 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ASPINE USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
Device Description
The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use.
The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows:
- a) 5 mm diameter, 5 mm high
- b) 5 mm diameter, 3 mm high
- c) 3 mm diameter, 3 mm high
The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.
Ask a Question
Page 1 of 1